ISA 95: Analyse-Tool für die MES-Einführung

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1 ISA 95: Analyse-Tool für die MES-Einführung Vision Pharma 2012, Karlsruhe Thomas Halfmann Besuchen Sie uns auch 2013 vom 5. bis 7. Februar wieder auf der Vision Pharma! Halfmann Goetsch Peither AG

2 Disclaimer Diese Präsentation unterliegt dem Urheberrecht. Jede Weiterverwendung von Bildern, Grafiken, Texten und anderen Inhalten ist ohne schriftliche Genehmigung der Halfmann Goetsch Peither AG unzulässig. Eine Genehmigung kann unter den am Ende angegebenen Kontaktadressen eingeholt werden. 2

3 Overview This presentation provides an overview on What is ISA-95 What are the benefits of ISA-95 How can ISA-95 be used as an analysis tool for MES projects 3

4 Why ISA-95? ISA-95 Enterprise Control System Integration Heavy investments have been made in ERP systems and automation of the processes control layer (PCS) In many production sites we are facing a gap between those two layers, i.e. between business automation and process automation ERP systems need data! However most of the data is provided manually Although integration of ERP systems and control systems provides important strategic advantages, many companies do not maintain a centralized information and automation integration strategy 4

5 Why ISA-95? IT and automation departments must handle a heterogeneous landscape of systems, different technology, user interfaces, data models, etc. Even worse: often automation engineers and IT staff do not have a sound understanding of each others field of work! Babylonian confusion begins Many stakeholders are usually involved in production automation projects (e.g. MES implementation) which requires good communication between the various stakeholders, but also between systems ISA-95 helps to speak the same language! 5

6 What is ISA-95? ISA-95 is not a language! ISA-95 is not an automation system! ISA-95 is a method, a way of working, thinking, and communicating ISA-95 contains models and terminology that can be used to analyze a manufacturing organization ISA-95 compromises of the following publications: Part 1: Models and Terminology Part 2: Object Model Attributes Part 3: Activity Models of Manufacturing Operations Management Part 4: Object models and attributes of manufacturing operations management activities (not published yet) Part 5: Business-to-Manufacturing Transactions Part 6: Manufacturing operations transactions (not published yet) 6

7 ISA-95 - Functional Hierarchy Model Level 4 Business Planning & Logistics Plant Production Scheduling, Operational Management, etc Establishing the basic plant schedule - production, material use, delivery, and shipping. Determining inventory levels. ERP (SAP) Months, weeks, days Level 3 Manufacturing Operations Mgmt. Dispatching Prod., Detailed Production Scheduling,... Work flow control to produce the desired end products. Maintaining records and optimizing the production process. MES, LIMS, WMS Days, shifts, hours, minutes, seconds Level 2 Level 1 Batch Control Continuous Control Discrete Control Monitoring, supervisory control and automated control of the production process SCADA, DCS Sensing the production process, manipulating the production process Hours, minutes, seconds Level 0 The actual production process 7

8 Equipment Hierarchy Model Enterprise Site Area Process Cell Production Unit Production Line Storage Zone Work Centers Unit Unit Work Cell Unit Unit Work Cell Storage Storage Unit Unit Work Units 8

9 Information Exchange Model Business Planning & Logistics Information Plant Production Scheduling, Operational Management, etc. ERP (SAP) Product definition information Production capability information Production schedule information Production performance information (What must be defined to make a product) (What resources are available) (What actual Production will be executed) (What actual production was achieved) Manufacturing Operations & Control Information Production Operations, Maintenance Operations, Quality Operations, etc. MES 9

10 Application Examples of ISA-95 Using ISA-95 (part 2) as a basis for developing software with MES functionality Using ISA-95 (parts 1, 2 and 5) for standardized information exchange between enterprise and control systems Using ISA-95 (parts 1 and 3) as an analysis tool Part 1: Reference model for evaluation of requirements and assessment which solution best fits Part 3: Reference model for data flow of manufacturing information that enables enterprise-control system integration 10

11 ISA-95 as Analysis Tool Objectives Providing a reference model for integration of enterprise and process control information Closing the gap between business automation and process automation Providing transparency of data and information requirements and flows Basis for definition of a corporate information and automation integration strategy Evaluation of requirements for implementation of a new Manufacturing Execution System 11

12 Steps of an ISA-95 Analysis 1. Start with a plant tour 2. Define scope and business drivers Conduct workshops and interviews based upon: 3. Functional Hierarchy Model 4. Equipment Hierarchy Model 5. Functional Enterprise - Control Model 6. Production Operations Management Activities Model 7. Maintenance Operations Management Activities Model 8. Quality Test Operations Management Activities Model 9. Inventory Operations Management Activities Model 10. Other activities 12

13 1. Production Plant Tour Familiarize yourself with actual production processes Depending on the scope of the analysis, the plant tour includes Manufacturing Warehouse Quality control laboratory Maintenance department Focus on such things as Material flow, material transport, user / machinery interactions, department interfaces, process flow, information flow, information handling, storage locations, order processing time, 13

14 2. Define Scope and Business Drivers Conduct Scope & Business Drivers workshop with members of the management team Accurately determination of the ISA-95 analysis scope Sound understanding of the company s business drivers Business drivers generate the need for information to flow between the executive offices and the process or manufacturing floor Examples for business drivers Available to promise Reduced cycle time Asset efficiency Agile manufacturing Supply chain optimization Quality and traceability Improved planning Annex C of ISA-95 Part 1 provides an overview about business drivers and key performance indicators 14

15 ISA-95 Workshops & Interviews Facilitate workshops and / or conduct interviews with all departments, that have been identified during the preparation phase of the ISA-95 Analysis with the following objectives: Gather all relevant information for the subsequent steps 3 to 10 Structure and document all relevant information Use a standardized reference model for recurring analyses, e.g. for multi-site MES implementation programs and brown-field implementation projects Safeguard the scope of the analysis 15

16 ISA-95 Workshops & Interviews Example for structuring the workshop and interview results: Process Segment: Description of the current process E.g.: use cases Information Flow E.g.: workflow diagrams Points of Concern E.g.: implementation risks Current Automation Systems E.g.: available systems and architecture Requirements E.g.: required features and processes Nice-to-have E.g.: wish list, to be decided for future steps Fit-Gap Assessment As-is vs. to-be status 16

17 3. Functional Hierarchy Model Assign ISA-95 to department responsibilities Activities fall within a control domain if the department is directly involved or if one of the following conditions applies: Activity is critical to plant safety Activity is critical to plant reliability Activity is critical to plant efficiency Activity is critical to product quality Activity is critical to maintaining regulatory compliance 17

18 4. Equipment Hierarchy Model (Example) Enterprise Site Area Work Center Work Unit HGP Basel Solid Dosage Production Bulk processing Mixer Granulator Tablet Press Packaging Liquid Production Singapore Distribution Warehouse 18

19 4. Equipment Hierarchy Model (simplified) ERP MES Out of scope Source: ANSI/ISA-95 19

20 5. Functional Enterprise-Control Model Start with Level 4 functions and go into more depth on Level 3 functions and activities using the operations management models for Production Maintenance Quality Assurance Inventory All subsequent workshops and interviews are based on the models in Part 3 of ISA-95 20

21 6. Production Operations Mgmt. Model Source: ANSI/ISA-95 21

22 6. Production Operations Mgmt. Model Example: Detailed activity Resource Management Source: ANSI/ISA-95 22

23 7. Maintenance Operations Mgmt. Model Source: ANSI/ISA-95 23

24 8. Quality Test Operations Mgmt. Model Source: ANSI/ISA-95 24

25 9. Inventory Operations Mgmt. Model Source: ANSI/ISA-95 25

26 10. Other Activities In addition to the major activities already described, there are other activities that are used within manufacturing operations, e.g.: Management of security within manufacturing operations Management of information within manufacturing operations Management of configurations within manufacturing operations Management of documents within manufacturing operations Management of regulatory compliance within manufacturing operations Management of incidents and deviations within manufacturing operations 26

27 10. Other Activities Source: ANSI/ISA-95 27

28 Lessons Learnt Explain the method and background to all participants Plan enough time for the workshops and interview sessions especially for processing of information and follow up Never skip the Business Drivers step and ensure that management provides their input Stay within and safeguard the scope Determine the level of detail that is required Conclude a final review of the analysis results and conclusion Inform all participants about the results Beware of politics 28

29 Conclusion An ISA-95 Analysis can be a very powerful and efficient tool to Determine and / or adjust your information and automation integration strategy Assess the need for manufacturing automation, e.g. MES, LIMS, WMS Evaluate the scope and system for Electronic Batch Records implementation 29

30 Contact Halfmann Goetsch Peither AG St. Alban Vorstadt 94 CH-4052 Basel Switzerland W E T

31 Follow Me HGPAG 31

32 HGP Group HGP Deutschland GmbH Schopfheim, Germany HGP Headquarter Basel, Switzerland HGP Asia Pte Ltd. Singapore 32

33 HGP Service Portfolio Improvement of Production Processes (LEAN) GLP Consulting (Good Laboratory Practice) Implementation of Paperless Manufacturing (MES) IT Quality and Compliance Management (COBIT) GMP Consulting (Good Manufacturing Practice) Computer System Validation (GAMP) Internal Control Systems and Risk Management (COSO, SOX) Retrofit of Pharmaceutical Machinery 33

34 HGP Skills Profile HGP consultants have multiple years healthcare industry experience Skills and education cover all domains of the healthcare industry Marketing, Manufacturing, Quality Assurance, Finance, IT, Automation, Engineering, Risk Management, Auditing, Pharmacists, Engineers, Economists, 34

35 HGP Tools RiColution the HGP application to manage risks and compliance effectively and efficiently! ISA 95 Analysis the powerful and efficient tool to determine information and automation integration strategy, evaluate the scope and system for EBR implementation! Reality Check an analysis that helps to show weaknesses quickly and accurately and identify the potential for optimization! As easy as playing a game! 35

36 HGP Training Curriculum (1) How to Survive in the Jungle of GMP The World of GMP GMP in Practice Critical GMP Aspects Validation of Computerized Systems What is CSV? Introduction into GAMP 5 How Much Validation Is Enough? The Mystic 11 Annex 11 and 21CFR11 The New Annex 11 to the EU / PIC/S Guidelines of GMP 21CFR11 Electronic Records & Electronic Signatures Implementation and Validation Aspects ISA 95 Analysis A Powerful Analysis Tool for Process and Automation Design What is ISA 95? Hands-on ISA 95 Analysis Training 36

37 HGP Training Curriculum (2) IT Risk Management Risk & Compliance Management IT Frameworks & IT Controls How to Implement IT Risk Management Effectively Implementation of Electronic Batch Records Fundamentals Technical Solutions (Overview) Implementation Strategy and Methods How to Prepare for an Audit Audit Preparation Activities Auditee Briefing The Audit Process Visit out website or ask your HGP consultant for the actual training curriculum, upcoming events or a tailored training course There is more to come! 37

38 Vision Pharma 2013 Besuchen Sie und auch im nächsten Jahr wieder auf der Vision Pharma 2013! 5. bis 7. Februar

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